System and methods for performing dynamic pedicle integrity assessments

Abstract

The present intention involves systems and related methods for performing dynamic pedicle integrity assessments involving the use of neurophysiology.

1. A method for performing pedicle integrity assessments, comprising the steps of:
 (a) establishing electrical communication between a stimulation element and an interior of a pedicle hole with an electrical coupling mechanism having a plunger with an electrical contact surface electrically coupled to a stimulation source during at least one of pilot hole formation, pilot hole preparation, and pedicle screw introduction; 
 (b) applying a stimulation signal to said stimulation element; and 
 (c) monitoring to assess whether nerves adjacent said pedicle are innervating as a result of the step of applying said application of stimulation signal to said stimulation element. 
 
   
   
     2. The method of  claim 1  and further, including the further step of providing an insulation member through which said stimulation element is passed. 
   
   
     3. The method of  claim 2  and further, wherein step (a) of establishing electrical communication between said stimulation element and said interior of said pedicle hole is accomplished by at least one of: (i) disposing a K-wire through said insulation member such that said K-wire contacts a pedicle screw during introduction into said pedicle hole; (ii) disposing said K-wire through said insulation member such that said K-wire contacts said interior of said pedicle hole during hole formation; (iii) disposing a tap member through said insulation member such that said tap member contacts said pedicle hole during hole preparation; and (iv) disposing a pedicle screw through said insulation member such that said pedicle screw contacts said pedicle hole during screw introduction. 
   
   
     4. The method of  claim 1  and further, comprising the step (d) of displaying at least one of alpha-numeric and graphical information to a user regarding whether nerves adjacent said pedicle innervate as a result of applying said stimulation signal to said stimulation element. 
   
   
     5. The method of  claim 1  and further, wherein said method may be performed in at least one of a percutaneous procedure, an open medical procedure, and a minimally invasive medical procedure. 
   
   
     6. The method of  claim 1  and further, comprising the additional step of providing an insulation member trough which the stimulation element is passed, the insulation member comprising, a flexible hollow elongated sheath having a proximal end, a distal end, an interior lumen, and a substantially enclosed seal tip attached to said distal end of said hollow elongated member, wherein said seal tip includes an expandable aperture for receiving said stimulation element. 
   
   
     7. A system for performing pedicle integrity assessments, comprising:
 a medical instrument for use in at least one of pedicle hole formation, hole preparation, and pedicle screw insertion at a pedicle target site, said pedicle target site in the general location of neural structures; 
 a sensor configured to detect a voltage response from muscles associated with said neural structures; 
 control unit coupled to said medical instrument and the sensor, the control unit being configured to (a) transmit a stimulation signal to said medical instrument, (b) receive a voltage response from the sensor, and (c) determine whether said neural structures are innervating as a result of the step of applying said application of stimulation signal to said medical instrument; and 
 an electrical coupling mechanism having a plunger with an electrical contact surface electrically coupled to said control unit for coupling said medical instrument to said control unit. 
 
   
   
     8. The system of  claim 7  and further, including an insulation member through which said medical instrument is passed. 
   
   
     9. The system of  claim 8  and further, wherein said medical instrument is at least one of (i) a K-wire disposed through said insulation member such that said K-wire contacts a pedicle screw during introduction into said pedicle hole; (ii) a K-wire disposed through said insulation member such that said K-wire contacts said interior of said pedicle hole during hole formation; (iii) a tap member disposed through said insulation member such that said tap member contacts said pedicle hole during hole preparation; and (iv) a pedicle screw disposed through said insulation member such that said pedicle screw contacts said pedicle hole during screw introduction. 
   
   
     10. The system of  claim 7  and further, comprising a display for displaying at least one of alpha-numeric and graphical information to a user regarding whether nerves adjacent said pedicle innervate as a result of applying said stimulation signal to said medical instrument. 
   
   
     11. The system of  claim 7  and further, wherein the system may be employed in at least one of a percutaneous procedure, an open medical procedure, and a minimally invasive medical procedure. 
   
   
     12. The system of  claim 7  and further, comprising an electrical coupling mechanism having a plunger with an electrical contact surface electrically coupled to said control unit for coupling said medical instrument to said control unit. 
   
   
     13. A method for performing pedicle integrity assessments, comprising the steps of:
 (a) providing an insulation member through which a stimulation element is passed, the insulation member comprising a flexible hollow elongated sheath having a proximal end, a distal end, an interior lumen, and a substantially enclosed seal tip attached to said distal end of said hollow elongated member, wherein said seal tip includes an expandable aperture for receiving said stimulation element; 
 (b) establishing electrical communication between a stimulation element and an interior of a pedicle hole with an electrical coupling mechanism having a plunger with an electrical contact surface electrically coupled to a stimulation source during at least one of pilot hole formation, pilot hole preparation, and pedicle screw introduction; 
 (c) applying a stimulation signal to said stimulation element; and 
 (d) monitoring to assess whether nerves adjacent said pedicle are innervating as a result of the step of applying said application of stimulation signal to said stimulation element. 
 
   
   
     14. The method of  claim 13  and further, wherein said hollow elongated sheath is composed of at least one of polyurethane film, rubber, plastic, resilient polymer, elastomer, polyester, polyimide, silicicone, fluoropolymer, and polytetrafluoroethylene. 
   
   
     15. The method of  claim 13  and further, wherein said hollow elongated sheath is compressible. 
   
   
     16. The method of  claim 13  and further, wherein said seal tip is composed of at least one of polyurethane film, rubber, plastic, resilient polymer, elastomer, polyester, polyimide, silicicone, fluoropolymer, and polytetrafluoroethylene. 
   
   
     17. The method of  claim 13  and further, wherein said expandable aperture is dimensioned to create a flush interaction with said stimulation element. 
   
   
     18. A system for performing pedicle integrity assessments, comprising:
 a medical instrument for use in at least one of pedicle hole formation, hole preparation, and pedicle screw insertion at a pedicle target site, said pedicle target site in the general location of neural structures; 
 an insulation member through which said medical instrument is passed comprising a flexible hollow elongated sheath having a proximal end, a distal end, an interior lumen, and a substantially enclosed seal tip attached to said distal end of said hollow elongated member, wherein said seal tip includes an expandable aperture for receiving said medical instrument; 
 a sensor configured to detect a voltage response from muscles associated with said neural structures; 
 a control unit coupled to said medical instrument and the sensor, the control unit being configured to (a) transmit a stimulation signal to said medical instrument, (b) receive a voltage response from the sensor, and (c) determine whether said neural structures are innervating as a result of the step of applying said application of stimulation signal to said medical instrument; and an electrical coupling mechanism having a plunger with an electrical contact surface electrically coupled to said control unit for coupling said medical instrument to said control unit. 
 
   
   
     19. The system of  claim 18  and further, wherein said hollow elongated sheath is composed of at least one of polyurethane film, rubber, plastic, resilient polymer, elastomer, polyester, polyimide, silicicone, fluoropolymer, and polytetrafluoroethylene. 
   
   
     20. The system of  claim 18  and further, wherein said hollow elongated sheath is compressible. 
   
   
     21. The system of  claim 18  and further, wherein said seal tip is composed of at least one of polyurethane film, rubber, plastic, resilient polymer, elastomer, polyester, polyimide, silicicone, fluoropolymer, and polytetrafluoroethylene. 
   
   
     22. The system of  claim 18  and further, wherein said expandable aperture is dimensioned to create a flush interaction with said medical instrument.